Expert panel recommends major reforms to FDA
Business as usual is not going to cut it at the Food and Drug Administration in 2023. Pushing through a rocky 2022, the FDA recently received recommendations from an outside expert panel that would reinvent the agency structure and culture if implemented.
The Operational Evaluation of the FDA Human Foods Program report was released Dec. 7 by the Reagan-Udall foundation at the behest of FDA Commissioner Robert Califf. Initial responses to the report have been positive from food and consumer groups alike.
“Today’s report is a very encouraging first step that will hopefully translate into meaningful reform within the FDA foods program,” Brian Ronholm, director of food policy for Consumer Reports, said in a news release. “We cannot afford to tolerate the status quo and let this moment go by without adopting fundamental changes to improve the FDA’s ability to protect the public and ensure our food is safe.”
The report validates many of the criticisms raised by advocates and industry leaders in recent months. What’s more, the panel’s formal acknowledgment that "serious problems" exist in the FDA food program is significant, as this will compel the agency to act on reforms, Ronholm said in a video press briefing.
Fresh produce leaders respond
Emily Griep, International Fresh Produce Association vice president of regulatory compliance and global food safety, shares the positive sentiment.
“IFPA is very grateful for the release of today’s report from the Reagan-Udall foundation,” Griep said in the briefing. “We agree with the report's recommendations for the need for a strong, supportive, singular leadership with clear lines of authority within the FDA’s human foods programs to help break down interagency silos and provide overall improvements to the culture of the human foods program."
The report, Griep said, provided a clear and strong approach to bring the agency back to the “prevention-focused mindset established in the Food Safety Modernization Act.”
“To do this, some structural changes are needed. And this was a major theme identified by the review panel,” Griep continued. “We feel these changes will go a long way in supporting the necessary cultural change, allowing clear decision making and effective use of the agency's existing and future resources.”
Broadly, fresh produce advocates and industry leaders say they are relieved and hopeful that the report will empower necessary changes long overdue at the FDA.
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“We are very pleased and thankful for the expert panel’s dedication to this report,” De Ann Davis, senior vice president of science for Western Growers, said in the video briefing. “We think it reflects many of the conversations that we’ve had and recommendations that we made, including the need for a single point of leadership for the agency when it comes to human foods program.
"We are also appreciative of the panel’s acknowledgement of the need for a prevention focus by the agency when it comes to the safety of the nation’s food. This was the original intention of the Food Safety Modernization Act, and we are very grateful for the call to see it reestablished,” Davis continued. “With more than 20,000 farms in California alone that provide produce to the nation, we acknowledge that the best way to continue to achieve food safety is through prevention-based programs rather than compliance.”
Mounting pressure on the FDA to act in 2022
Faced with a series of back-to-back challenges that tested and stressed FDA operations, early 2022 was anything but smooth sailing for the agency. Exposés and pushback beset the FDA, culminating with a coalition of food and public health consumer groups — including the IFPA, Western Growers, FMI and others — petitioning the FDA to empower a deputy commission for foods.
In July 2022, Califf responded to pressure to take a closer look at how the FDA does business and reached out to an independent expert panel to evaluate the current FDA Human Foods Program.
The panel, convened by the Reagan-Udall Foundation, was asked to evaluate the program within a 60-day period and offer recommendations to strengthen the FDA’s food regulatory role. Califf acknowledged in the report that while Americans generally have access to safe and nutritious food, the FDA was “challenged by our nation’s endlessly complex food systems and supply chain.”
Now that an expert evaluation and recommendations have been shared, Congress would need to enact these new policy recommendations with appropriate resources and funding. Reforms that cover the gamut of FDA topics — improving food safety prevention strategies all the way to aspirational plans of creating an entirely new center focused on nutrition — are only possible with funding that can turn words into boots-on-the-ground action.
